BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 CRYOSURGICAL

    MDR report key: 10521209 · Received September 11, 2020

    Report

    Report Number
    1216677-2020-00207
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Date of Event
    August 5, 2020
    Report Date
    January 20, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    UDI-DI
    00888937010077
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INSPECT RETURNED SAMPLES DISTRIBUTION HISTORY: THIS COMPLAINT UNIT WAS MANUFACTURED IN 1997. MANUFACTURING RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE RECORD COULD NOT BE LOCATED AT THE TIME OF THIS INVESTIGATION. HOWEVER, IT SHOULD BE NOTED AT THE TIME OF MANUFACTURE RECORDS FROM EACH LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL COOPERSURGICAL QUALITY RELEASE SPECIFICATIONS. SHOULD THE DEVICE HISTORY RECORD BE LOCATED GOING FORWARD, IT WILL BE REVIEWED, AND THIS COMPLAINT AMENDED ACCORDINGLY. INCOMING INSPECTION REVIEW: NOT APPLICABLE. SERVICE HISTORY RECORD: NO ADDITIONAL SERVICE HISTORY RECORDS FOUND FOR THIS UNIT. HISTORICAL COMPLAINT REVIEW: A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED ONE SIMILAR REPORTED COMPLAINT CONDITION. THE COMPLAINT WAS NOT CONFIRMED. PRODUCT RECEIPT: THE COMPLAINT UNIT WAS RETURNED ON A REPAIR. VISUAL EVALUATION: VISUAL EXAMINATION OF THE COMPLAINT UNIT REVEALED PHYSICAL DAMAGE ON THE FREEZE TRIGGER. FUNCTIONAL EVALUATION: COMPLAINT UNIT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. ROOT CAUSE: THE ROOT CAUSE IS BEING ATTRIBUTED TO END USER ERROR. THE DAMAGE IS CONSISTENT WITH THE COMPLAINT DESCRIPTION. THE TRIGGERS ARE NEXT TO EACH OTHER AND WORK TOGETHER. AS ONE WAS BROKEN OFF IT IS EXPECTED THE OTHER WILL NOT WORK. IN THIS CASE THE FROST TRIGGER WAS BROKEN OFF AND IT AFFECTED THE DEFROST TRIGGER. CORRECTIVE ACTIONS THE UNIT WAS REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. NO FURTHER CORRECTIVE ACTION IS NECESSARY. NO FURTHER TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED: ""DEFROST BUTTON INTERMITTENTLY NOT WORKING - ONCE DEPRESSED HAVE TO WAIT ABOUT 2 MINUTES FOR GUN TO DEFROST". 1216677-2020-00207-1 900001 LL100 CRYOSURGICAL (B)(4)

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL , INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITON.

    Description of Event or Problem · 1

    CUSTOMER STATED "DEFROST BUTTON INTERMITTENTLY NOT WORKING - ONCE DEPRESSED HAVE TO WAIT ABOUT 2 MINUTES FOR GUN TO DEFROST." REPAIR TECH STATED "CONFIRMED COMPLIANT: FREEZE TRIGGER BROKEN OFF AND DEFROST TRIGGER WILL NOT UNLOCK REMAINING PIECE OF FREEZE TRIGGER." REF: E-COMPLAINT-(B)(4). LL100 CRYOSURGICAL 900001 E-COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990253 LL100 CRYOSURGICAL LL100 CRYOSURGICAL GEH COOPERSURGICAL, INC. 900001 N/A 00888937010077

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other